Cautions
Contraindications
- Known hypersensitivity to albuterol or any ingredients in the formulations.
- Known history of hypersensitivity to soya lecithin or related food products such as soybeans or peanuts; atropine and its derivatives; or any other ingredient in the specific formulation (albuterol sulfate in fixed combination with ipratropium bromide).
Warnings/Precautions
Warnings
Acute or Worsening Asthma
Oral inhalation therapy is intended for the acute symptomatic relief of bronchospasm. If control of mild asthma deteriorates such that regular (i.e., exceeding 4 times daily) use of a short-acting β2-agonist becomes necessary, institute maintenance therapy (e.g., inhaled corticosteroids and/or mast cell stabilizers, long-acting bronchodilators [e.g., inhaled salmeterol] or oral extended-release drugs) and discontinue regular use of short-acting β2-agonists in such patients; instead, use short-acting β2-agonists only as a supplement for relief of acute asthma symptoms. Contact a clinician for reevaluation if control of mild asthma deteriorates.
Failure to respond to a previously effective dosage of albuterol may indicate seriously worsening asthma. Reevaluate asthma therapy and institute alternative regimens or therapy. Discontinue and contact a clinician if decreased effectiveness occurs; do not increase the dose or frequency of administration.
Excessive Doses
Possible fatalities associated with excessive use of inhaled sympathomimetic drugs. The safety of concomitant use of >8 inhalations per day of a short-acting β2-adrenergic agonist with a long-acting β2-agonist (e.g., salmeterol) oral inhalation therapy has not been established. (See Sympathomimetic Agents under Interactions.)
Paradoxical Bronchospasm
Possible life-threatening, acute paradoxical bronchospasm. Frequently occurs with the first use of a new canister or vial (oral inhalation aerosol), but also may occur with orally administered conventional or extended-release tablets.
Discontinue therapy immediately if bronchoconstriction occurs and institute alternative therapy.
Cardiovascular Effects
Possible clinically important cardiovascular effects, including cardiac arrhythmias (e.g., atrial fibrillation, supraventricular tachycardia, extrasystoles) , increased or decreased BP, and related symptoms.
Cautious use recommended in patients with cardiovascular disorders (e.g., coronary insufficiency, cardiac arrhythmias), hypertension, and those with sensitivity to sympathomimetic amines. May require drug discontinuance.
Sensitivity Reactions
Immediate hypersensitivity reactions (e.g., urticaria, angioedema, rash, bronchospasm, anaphylaxis, oropharyngeal edema) have been reported. Possible acute bronchospasm. (See Paradoxical Bronchospasm under Cautions.)
General Precautions
Nervous System Effects
Possible CNS stimulation and adverse nervous system effects.
Cautious use recommended in patients with seizure disorders and in those with sensitivity to sympathomimetic amines.
Metabolic Effects
Possible hypokalemia, which may increase risk of adverse cardiovascular effects. (See Cardiovascular Effects under Cautions.) Serum potassium decrease generally is transient and usually does not require supplementation.
Diabetes mellitus or increased blood glucose in patients receiving orally inhaled or nebulized albuterol.
Cautious use recommended in patients with diabetes mellitus or hyperthyroidism.
GI Effects
Possible GI obstruction when extended-release tablets are used in patients with preexisting GI narrowing; cautious use recommended.
Specific Populations
Pregnancy
Category C.
Lactation
Not known whether albuterol is distributed into milk. Discontinue nursing or the drug.
Pediatric Use
Safety and efficacy of certain orally inhaled albuterol sulfate inhalation aerosols (Proventil HFA®, Ventolin® HFA) not established in children <4 years of age. Safety and efficacy of orally inhaled racemic albuterol aerosol (Proventil®, ProAir® HFA) or albuterol sulfate inhalation solution (Proventil®) not established in children <12 years of age. Safety and efficacy of some albuterol inhalation solutions for nebulization (e.g., AccuNeb®, albuterol sulfate 0.083%) not established in children <2 years of age. Safety and efficacy of albuterol sulfate in fixed combination with ipratropium bromide not established in pediatric patients <18 years of age.
Safety and efficacy of albuterol conventional and extended-release tablets not established in children <6 years of age. Safety and efficacy of albuterol sulfate oral solutions not established in children younger <2 years of age.
Geriatric Use
No overall differences in safety and efficacy observed between geriatric and younger patients for albuterol sulfate in fixed combination with ipratropium bromide inhalation solution. Special caution should be used in geriatric patients who have cardiovascular disease. (See Cautions: Cardiovascular Effects.) Cannot rule out possibility that some geriatric patients may exhibit increased sensitivity to the drug. Substantially eliminated by kidneys; assess renal function periodically since geriatric patients more likely to have decreased renal function. Risk of toxicity greater in patients with renal impairment, including geriatric patients.
Common Adverse Effects
Albuterol or albuterol sulfate: Tremor, asthma exacerbation, bronchospasm, nervousness, shakiness, otitis media, nausea, cough, bronchitis, headache, tachycardia/palpitations, muscle cramps, hypokinesia, insomnia, weakness, dizziness, excitement, hyperactivity, increased appetite, flu syndrome, lymphadenopathy, skin/appendage infection, urticaria.
Albuterol sulfate in fixed combination with ipratropium bromide: Bronchitis, upper respiratory tract infection, lung disease, headache, dyspnea, pharyngitis, coughing, chest pain, pain, respiratory disorder, sinusitis, nausea, diarrhea, urinary tract infection, influenza, pneumonia, leg cramps, dyspepsia, constipation, voice alterations, bronchospasm.
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